Herb composition for treating lung cancer and preparation method thereof

ABSTRACT

The present invention provides a composition for treating cancers, which comprises (a) pharmaceutically acceptable carriers and (b) an effective amount of an aqueous or aqueous organic solvent extract of a crude preparation comprising  Semen Trigonellae, Astragali Radix, Glehniae Radix , and  Asparagi Radix . The preferred composition further comprises the extract of other anti-tumor medicinal materials, such as  Fructus Ligustri Lucidi , or  Herba Selaginellae Doederleinii . The present invention also provides the preparation method and use of the composition in treating cancers, especially lung cancers.

FIELD OF THE INVENTION

The present invention relates to a herb preparation and composition fortreating tumors/cancers and, in particular, to a medicinal herbcomposition for treating lung cancers containing Semen Trigonellaeextract and the preparation method thereof.

BACKGROUND OF THE INVENTION

Currently, the available treatment methods for lung cancer includechemotherapy and radiotherapy. However, the patients suffer intense painfrom such treatment while the efficacy is far from satisfactory.

U.S. Pat. No. 4,618,495 discloses a composition for reducing cancersymptoms, but not curing cancer, which comprises an aqueous or aqueousorganic solvent extract of one or more crude preparations selected fromthe group consisting of Astragali radix, Cinnamomi cortex, Rehmanniaeradix, Paeoniae radix, Cnidii rhizoma, Atractylodis lanceae rhizoma,Angelicae radix, Ginseng radix, and Glycyrrhizae radix.

U.S. Pat. No. 4,613,591 discloses a composition for increasing theanti-tumor activities of drugs such as mitomycin C and decreasing theside effects associated with their use. The composition comprises anaqueous or aqueous organic solvent extract of a crude preparation ofAstragali radix, Cinnamomi cortex, Rehmanniae radix, Paeoniae radix,Cnidii rhizoma, Atractylodis lanceae rhizoma, Angelicae radix, Ginsengradix, and Glycyrrhizae radix.

U.S. Pat. No. 6,379,714 discloses botanical materials as being of apharmaceutical grade containing fenugreek. The patent discloses theprocess of utilizing a whole or a selected part of the plant to form anaqueous or organic extract. The biological material can also beprocessed to form a powder. In general, extracts of the plant materialare preferred because they are easier to dissolve in liquidpharmaceutical carriers. However, powdered plant materials are wellsuited for many applications where the drug is administered in a solidform, e.g., tablets or capsules.

U.S. Pat. No. 6,495,175 discloses a process for obtaining usefulmaterials from fenugreek seeds. The patent discloses the importance ofdietary fiber including extracts from fenugreek seeds. A diet havingadequate amount of dietary fiber is important not only in preventing theorgan dysfunction but also in the treatment and management of diseases.Fiber deficiency is known to be a detrimental factor of severaldysfunction and diseases, such as heart failures, coronary arterydisease, diabetes, and constipation.

Fenugreek has been used in treating colic flatulence, dysentery,diarrhea, chronic cough, diabetes, and the like. The fenugreek seed isconsidered to be a tonic or dietary supplement. It has also been used inpost-natal care to enrich lactation in nursing mothers. Fenugreek seedhas also been used as a medicine for baldness and is being used as apart of hair tonics in some countries.

U.S. Pat. Nos. 6,291,533 and 6,503,529 disclose medical use of fenugreekseed for digestive problems. It acts as a laxative that lubricates theintestine of a patient. It also has a mild anti-inflammatory effectwhich makes it therapeutically effective for arthritis symptoms. Thisherb may also reduce cholesterol levels.

None of the above prior arts discloses the use of fenugreek extract as apharmaceutical agent for treating cancers and tumors, especially thelung cancers.

From the above discussion, it is concluded that there is no effectivedrug for treating cancers such as lung cancers. Therefore, there is anurgent need to develop a medicinal composition effective for treatinglung cancers and/or reducing the side effects associated with suchtreatment.

SUMMARY OF THE INVENTION

One object of the present invention is to provide a compositioneffective for treating lung cancers, and methods of preparation and usesthereof.

In the first aspect, the present invention provides a compositioncomprising (a) a pharmaceutically acceptable carrier or carriers and (b)an effective amount of an aqueous or aqueous organic solvent extract ofraw herbs, which comprises Semen Trigonellae, Astragali Radix, GlehniaeRadix, and Asparagi Radix.

In another preferred embodiment, the raw herbs further compriseanti-tumor medicinal materials selected from the group consisting ofFructus Ligustri Lucidi, Herba Selaginellae Doederleinii, andcombination thereof.

In another preferred embodiment, the raw herbs further compriseanti-tumor medicinal materials selected from the group consisting ofHerba Salviae Chinensis, Rhizoma Paridis, Salviae Chinensis Herba, HerbaHedyotidis Diffusae, Radix Sophorae Tonkinensis, Radix SophoraeFlavescentis, and combination thereof.

In another preferred embodiment, the raw herbs further compriseimmunity-enhancing medicinal materials selected from the groupconsisting of Radix Ophiopogonis, Herba Gynostemmae, Fructus Corni,Herba Epimedii, ginseng, Rhizome of Largehead Atractylodes, andcombination thereof.

In another preferred embodiment, the crude raw herbs comprise 0.5-5parts by weight Semen Trigonellae, 2-20 parts by weight Astragali Radix,2-10 parts by weight Glehniae Radix, 1-5 parts by weight Asparagi Radix,0.5-5 parts by weight Fructus Ligustri Lucidi, and 1-10 parts by weightHerba Selaginellae Doederleinii.

In another preferred embodiment, the raw herbs further comprise 1-10parts by weight Herba Salviae Chinensis, 1-5 parts by weight RhizomaParidis, 1-5 parts by weight Salviae Chinensis Herba, 1-10 parts byweight Herba Hedyotidis Diffusae, 1-5 parts by weight Radix SophoraeTonkinensis, 1-5 parts by weight Radix Sophorae Flavescentis, orcombination thereof; and

0.5-10 parts by weight Radix Ophiopogonis, 0.5-5 parts by weight HerbaGynostemmae, 0.5-5 parts by weight Fructus Corni, 0.5-5 parts by weightHerba Epimedii, 0.5-5 parts by weight ginseng, 0.5-5 parts by weightRhizome of Largehead Atractylodes, or combination thereof.

In another preferred embodiment, the raw herbs comprise:

0.5-5 parts by weight Semen Trigonellae, 2-20 parts by weight AstragaliRadix, 2-10 parts by weight Glehniae Radix, and 1-5 parts by weightAsparagi Radix;

0.5-5 parts by weight Fructus Ligustri Lucidi, and 1-10 parts by weightHerba Selaginellae Doederleinii;

1-10 parts by weight Herba Salviae Chinensis, and 1-5 parts by weightRhizoma Paridis; and

b 0.5-10 parts by weight Radix Ophiopogonis, 0.5-5 parts by weight HerbaGynostemmae, 0.5-5 parts by weight Fructus Corni, and 0.5-5 parts byweight Herba Epimedii.

In another preferred embodiment, the raw herbs comprise:

0.7-3 parts by weight Semen Trigonellae, 2.5-10 parts by weightAstragali Radix, 2.5-6 parts by weight Glehniae Radix, and 1.2-3.5 partsby weight Asparagi Radix;

0.7-3 parts by weight Fructus Ligustri Lucidi, and 2.5-6 parts by weightHerba Selaginellae Doederleinii;

2-8 parts by weight Herba Salviae Chinensis, and 1.2-3.5 parts by weightRhizoma Paridis;

0.7-5 parts by weight Radix Ophiopogonis, 0.7-3 parts by weight HerbaGynostemmae, 0.7-3 parts by weight Fructus Corni, and 0.7-3 parts byweight Herba Epimedii.

In the second aspect, the present invention provides a method forpreparing a composition comprising (a) a pharmaceutically acceptablecarrier or carriers and (b) an effective amount of an aqueous or aqueousorganic solvent extract of raw herbs comprised of Semen Trigonellae,Astragali Radix, Glehniae Radix, and Asparagi Radix, wherein the methodcomprises the following steps:

(a) mixing the raw herbs with water or aqueous solution containing30-85% (v/v) ethanol for 12-48 hours to form a mixture;

(b) filtering the mixture to obtain the filtrate and adjusting the pH offiltrate to 4-8, thereby obtaining an extract; or alternately adjustingthe pH of mixture to 4-8 and filtering the mixture to obtain thefiltrate, thereby obtaining an extract; and

(c) mixing the extract with pharmaceutically acceptable carriers,thereby forming a composition.

In another preferred embodiment, step (b) further comprises the step ofdrying the obtained extract.

In another preferred embodiment, the raw herbs further comprisemedicinal materials selected from the group consisting of FructusLigustri Lucidi, Herba Selaginellae Doederleinii, and combinationthereof; anti-tumor medicinal materials selected from the groupconsisting of Herba Salviae Chinensis, Rhizoma Paridis, SalviaeChinensis Herba, Herba Hedyotidis Diffusae, Radix Sophorae Tonkinensis,Radix Sophorae Flavescentis and combination thereof; andimmunity-enhancing medicinal materials selected from the groupconsisting of Radix Ophiopogonis, Herba Gynostemmae, Fructus Corni,Herba Epimedii, ginseng, Rhizome of Largehead Atractylodes, andcombination thereof.

In the third aspect, the present invention provides a method fortreating cancer comprising administering the composition to the patientin need. The composition comprises (a) pharmaceutically acceptablecarriers and (b) an effective amount of an aqueous or aqueous organicsolvent extract of raw herbs comprising Semen Trigonellae.

The composition preferably further comprises Astragali Radix, GlehniaeRadix, and Asparagi Radix. The composition more preferably furthercomprises Fructus Ligustri Lucidi and Herba Selaginellae Doederleinii.The composition most preferably further comprises any anti-tumormedicinal materials such as Herba Salviae Chinensis, Rhizoma Paridis,Salviae Chinensis Herba, Herba Hedyotidis Diffusae, Radix SophoraeTonkinensis, Radix Sophorae Flavescentis or combination thereof, andimmunity-enhancing medicinal materials such as Radix Ophiopogonis, HerbaGynostemmae, Fructus Corni, Herba Epimedii, ginseng, Rhizome ofLargehead Atractylodes or combination thereof.

In another preferred embodiment, the effective amount of the medicinalcomposition of the invention is 1-3 dosages per person per day, and eachdosage is equivalent to 0.5-15 grams (preferably 1-10 grams) of drySemen Trigonellae.

In the fourth aspect, the present invention provides the use of themedicinal composition and Semen Trigonellae in preparing medication fortreating tumors and cancers, especially lung cancers.

DETAILED DESCRIPTION OF INVENTION

The inventors have discovered that the aqueous or aqueous organicsolvent extract of Semen Trigonellae has a very goodanti-tumor/anti-cancer activity and can effectively enhance the immunityof tumor patients. On the basis of said discovery, the inventors hereindisclose the invention.

In another preferred embodiment, the invention may further comprise anaqueous or aqueous organic solvent extract of raw herbs comprisingAstragali Radix, Glehniae Radix, Asparagi Radix, Fructus LigustriLucidi, Herba Selaginellae Doederleinii or combination thereof.Preferably, the extract of the invention further comprises the extractof Astragali Radix, Glehniae Radix, and Asparagi Radix. These extractsprovide better efficacy against lung cancers.

In general, each raw herb exists in the mixture in the followingquantity (parts by weight): parts by weight preferred parts by weightSemen Trigonellae 0.5-5   0.7-3   Astragali Radix  2-20 2.5-10  GlehniaeRadix  2-10 2.5-6   Asparagi Radix 1-5 1.2-3.5 Fructus Ligustri Lucidi0.5-5   0.7-3   Herba Selaginellae  1-10 2.5-6   Doederleinii

In one preferred embodiment, the composition of the invention furthercomprises an aqueous or aqueous organic solvent extract of additionalanti-tumor medicinal materials. Exemplary anti-tumor medicinal materialsinclude, but are not limited to, Herba Salviae Chinensis, RhizomaParidis, Salviae Chinensis Herba, Herba Hedyotidis Diffusae, RadixSophorae Tonkinensis, Radix Sophorae Flavescentis or a combinationthereof.

In general, the amount of these additional anti-tumor medicinalmaterials is as follows: parts by weight preferred parts by weight HerbaSalviae Chinensis  1-10 2-8 Rhizoma Paridis 1-5 1.2-3.5 SalviaeChinensis Herba 1-5 1.2-3.5 Herba Hedyotidis Diffusae  1-10 2-8 RadixSophorae 1-5 1.2-3.5 Tonkinensis Radix Sophorae 1-5 1.2-3.5 Flavescentis

In another preferred embodiment, the composition of the inventionfurther comprises an aqueous or aqueous organic solvent extract ofadditional immunity-enhancing medicinal materials. Exemplaryimmunity-enhancing medicinal materials include, but are not limited to,Radix Ophiopogonis, Herba Gynostemmae, Fructus Corni, Herba Epimedii,ginseng, Rhizome of Largehead Atractylodes, or a combination thereof.

In general, the amount of these additional immunity-enhancing medicinalmaterials is as follows: parts by weight preferred parts by weight RadixOphiopogonis  0.5-10 0.7-5 Herba Gynostemmae 0.5-5 0.7-3 Fructus Corni0.5-5 0.7-3 Herba Epimedii 0.5-5 0.7-3 ginseng 0.5-5 0.7-3 Rhizome ofLargehead 0.5-5 0.7-3 Atractylodes

In one embodiment, the preferred extract of the invention is made from amixture which comprises the following medicinal materials: parts byweight preferred parts by weight Semen Trigonellae 0.5-5   0.7-3  Astragali Radix  2-20 2.5-10  Glehniae Radix  2-10 2.5-6   AsparagiRadix 1-5 1.2-3.5 Fructus Ligustri Lucidi 0.5-5   0.7-3   HerbaSelaginellae  1-10 2.5-6   Doederleinii Herba Salviae Chinensis  1-102-8 Rhizoma Paridis 1-5 1.2-3.5 Radix Ophiopogonis 0.5-10  0.7-5   HerbaGynostemmae 0.5-5   0.7-3   Fructus Corni 0.5-5   0.7-3   Herba Epimedii0.5-5   0.7-3  

As used in this disclosure and the claims, the term “raw herbs”, whichis also known as “medicinal materials” are defined as follows:

Semen Trigonellae: dry mature seed of Trigonelta Foenumgraecum(Leguminosae plant).

Astragali Radix, Radix Astragali or Astragalus root: Root of AstragalusMembranaceus Bunge or other varieties (genus Leguminosae, familyLeguminosae).

Glehniae Radix: root of GlehniaLlittoralis (family Umbelliferae).

Asparagi Radix: root of AsparagusCochinchinensis (family Liliaceae).

Fructus Ligustri Lucidi: fruit of Ligustrum Lucidum Ait (familyOleaceae)

Herba Selaginellae Doederleinii: whole herb of Selaginella DoederleiniiHieron (family Selaginellaceae).

Herba Salviae Chinensis: whole herb of Salvia Chinensis Benth (familyLabiatae)

Rhizoma Paridis: root or stem of Paris Polyphylla Smith or othervarieties (family Liliaceae)

Radix Ophiopogonis: root of Ophiopogon Japonicus Ker-Gawl (familyLiliaceae)

Herba Gynostemmae: whole herb of Gynostemma Pentaphyllum Makino (familiyCururbitaceae)

Fructus Corni: fruit of Cornus Officinalis seib. et zucc (familyCornaceae)

Herba Epimedii: the overground part of Epimedium Brevicornu Maxim orother varieties (family Berberidaceae)

Salviae Chinensis Herba: pistil or whole herb of Prunella Vulgaris Linn.

Herba Hedyotidis Diffusae: root-containing whole herb of HedyotisDiffusa Willd.

Radix Sophorae Tonkinensis: root of Sophora Subprostrata Chun or othervarieties

Radix Sophorae Flavescentis: root of Sophora Flavescens Ait. or othervarieties

Ginseng: root of Panax Ginseng

Rhizome of Largehead Atractylodes: root or stem of AtractylodesMacrocephala Koidz

The active ingredient of the invention, i.e., the extract of the rawherbs, can be prepared as follow: extracting the desired raw herbs withwater or aqueous solution containing 30-85% (v/v) water miscible organicsolvent such as alcohol (e.g., ethanol); filtering the extractedsolution and drying the filtrate by selected conventional methods suchas spray drying, lyophilization, or concentration-and-drying. The activeingredient of the invention can be prepared by mixing each extract ofraw herbs or by extracting the mixture of raw herbs.

The extraction can be carried out at room temperature or under heatedconditions, preferably at 4-35° C., more preferably at 5-30° C.

One preferred method of extraction is percolation described as follows:

Raw herbs pulverized as powder (average grain diameter 200-1000 μm,preferably 250-850 μm) are placed into a cylindrical container which hasa partition at the bottom. Use ethanol aqueous solution as solvent toflow from the top downward through the powder placed on the partition.The concentration of the solvent is 30-85% (v/v), preferably 40-70%, andmore preferably 45-65%. The amount of solvent is 4-30 times andpreferably 6-20 times that of the total weight of the raw herbs. Thepulverized raw herbs may be immersed in the solvent for 12-48 hours, andpreferably 16-36 hours and then be percolated. There is no speciallimitation to the rate of percolation. Preferably, the rate is 0.5-10ml/kg raw herbs per minute, and more preferably 1-5ml/kg raw herbs perminute. The effluent liquid is collected and concentrated by vacuumdrying or heat drying until the weight of the concentrated solution is0.5-1.5 (preferably 0.6-1.2) times of the total weight of the raw herbs.The concentrated solution is filtered to remove solid residues. The pHof the filtrate is adjusted to 4-8, preferably 4.5-7.5 by adding a baseto obtain the liquid extract of the invention.

In another preferred embodiment, flavoring agents (e.g., sugar),preservative agents (e.g., sodium benzoate) and/or other additives areadded into the liquid extract to form an oral solution.

Moreover, the liquid extract can be dried by conventional methods suchas spray drying, lyophilization, or concentration-and-drying to obtainsolid extract. These solid extracts may be mixed with auxiliaryadditives or excipients to form various types of drugs, such as tablets,capsules, granules, etc.

In general, the composition of the invention is formed simply by mixingthe extract of the invention with suitable carriers. There is no speciallimitation to the methods for preparing the composition of the inventionand various conventional methods in the art, e.g., mixing and the like,are useful in the present invention.

The composition of the invention can be mixed with various carriers tomake drug in different forms. The invention covers products in any formthat contains the composition of the invention together withpharmaceutically acceptable carriers or excipients.

As used herein, the term “the composition of the invention” includes anypharmaceutical composition or dietary supplement as long as they includethe extract of Semen Trigonellae, or the extract of Semen Trigonellaeand other medicinal materials. In one embodiment, the extract of SemenTrigonellae or the extract of Semen Trigonellae and other medicinalmaterials comprises 0.1-99 wt %, preferably 1-90 wt %, and mostpreferably 5-80 wt % of the total weight of the composition. In anotherembodiment, based on the dry weight of medicinal materials, one gramsolid composition or one milliliter of liquid composition is preferablyequivalent to 0.1-10 g, more preferably 0.2-5 g, most preferably 0.5-2.5g of total medicinal materials.

As used herein, the term “pharmaceutically acceptable carrier” refers toa carrier for administering a therapeutic agent and includes variousexcipients and diluents. The term refers to any pharmaceutical carrierwhich is not an active ingredient and may be consumed without unduetoxicity. Suitable carriers are well known to ordinary people skilled inthe pharmaceutical field. A thorough discussion of pharmaceuticallyacceptable excipients is available in Remington's PharmaceuticalSciences (Mack Pub. Co., N.J. 1991). Pharmaceutically acceptablecarriers may contain liquids such as water, saline, glycerol andethanol. Additionally, auxiliary substances, such as wetting oremulsifying agents, pH buffering substances, and the like, may also bepresent.

In addition, the formulation or composition of the invention may alsocomprise other compounds used in treating or assisting to treat cancers,such as cisplatin. The formulation or composition of the presentinvention may also be used in conjunction with the chemo-therapeutic orradio-therapeutic means.

The composition of the invention may also comprise at least onepharmaceutically acceptable additive, such as flavoring agent (e.g.,sucrose, fructose and the like), preservative agent (e.g., sodiumbenzoate and the like) and pigment. These additives are well known inthe pharmaceutical field.

The extract or composition of the invention can be used to treat variouscancers, especially lung cancers. They may be administered in variousways, including, but not limited to, oral, intramuscular,intraperitoneal, intravenous, subcutaneous, or local delivery.

When using composition of the invention, safe and effective amounts ofthe aqueous or aqueous organic solvent extract of Semen Trigonellae (ora mixture comprising Semen Trigonellae and other medicinal materials)are administered to mammals. Typically, a safe and effective amount is0.1-100 grams, preferably 0.5-50 grams of equivalent dry SemenTrigonellae per day per person. When mixed medicinal materials are used,the amount is calculated based on the amount of Semen Trigonellae in themixture. Of course, the precise amount will depend upon various factors,such as delivery methods, patient's health, and the like, and is withinthe scope of skilled clinicians.

The main advantages of the invention are as follow:

(a) The extract of Semen Trigonellae has demonstrated its effectivenessin treating lung cancers.

(b) The composition containing the extract of Semen Trigonellae andadditional medicinal materials has clearly demonstrated itseffectiveness in treating lung cancers.

The invention is further illustrated by the following examples. Theseexamples are only intended to illustrate the invention, but not to limitthe scope of the invention. For the experimental methods not specifiedin the following examples, they are performed under routine conditions,or as suggested by the manufacturers.

PREPARATION EXAMPLE NO. 1

The following amount of crude herb material was weighed. Amount (kg)Semen Trigonellae 1

The material was cleaned, dried and made into powder with an averagegrain size of about 250-300 μm. The powder was placed into a cylindricalcontainer having a partition at the bottom (that is, the solvent flowingfrom top to down and through the powder placed on the partition). Theaqueous solution containing 40%(v/v) ethanol was used as solvent. Theamount of solvent was 10 times of the total weight of the crudepreparation. The crude preparation was mixed with solvent and soaked for48 hrs before percolation. The rate of percolation was 0.5ml/kg crudepreparation per minute. The effluent liquid was collected andconcentrated by vacuum drying (<0.05 MPa) so that the weight of theconcentrated solution was {fraction (6/10)} of the total weight of thecrude preparation. The concentrated solution was filtered, therebyremoving solid residues. The pH of filtrate was adjusted to 5 by addingNaOH solution, thereby obtaining the liquid extract.

Sucrose and sodium benzoate were added into the obtained liquid extractto a final concentration of 5 wt % sucrose and 0.1 wt % sodium benzoate,thereby forming a total amount of 1000 ml for the oral solution A. Theconcentration was equivalent to 1 gram crude preparation per milliliter.

The solutions containing individual extract of Astragali Radix, GlehniaeRadix, Asparagi Radix, Fructus Ligustri Lucidi, or Fructus Corni wereprepared in the similar manner. The concentration of each solution wasequivalent to 1 gram crude preparation per milliliter.

PREPARATION EXAMPLE NO. 2 TO NO. 5

The process of Preparation Example No. 1 was repeated except that thefollowing crude preparations were used. Example Example Example ExampleExample No. 2 No. 3 No. 4 No. 5 No. 6 Amount Amount Amount Amount Amount(kg) (kg) (kg) (kg) (kg) Semen 1 1 0.5 1 3.5 Trigonellae Astragali 2.520 2 4 3 Radix Glehniae 2.5 10 2 2.5 3 Radix Asparagi 1.5 1.5 5 3.5 2.5Radix Fructus 1 0 5 2 1 Ligustri Lucidi Herba 2.5 0 10 5 1 SelaginellaeDoederleinii

The oral solution B (Example No. 2), oral solution C (Example No. 3),oral solution D (Example No. 4), oral solution E (Example No. 5) andoral solution F (Example No. 6) were prepared, respectively, wherein theconcentration of each solution was equivalent to 1 gram of total crudedry preparation per milliliter.

PREPARATION EXAMPLE NO. 6

The procedure of Preparation Example No. 2 was repeated except that acrude preparation was made into powder with an average grain size of700-850 μm, the aqueous solution containing 60%(v/v) ethanol was used assolvent in an amount of 6 times of the total weight of the crudepreparation and the soaking time was 20 hrs. The oral solution G wasprepared.

PREPARATION EXAMPLE NO. 7

The procedure of Preparation Example No. 2 was repeated except that thefollowing conditions were used. The rate of percolation was 4ml/kg crudepreparation per minute. The effluent liquid was collected andconcentrated by vacuum drying (<0.05 MPa) so that the weight of theconcentrated solution was 1.4 times of the total weight of the crudepreparation. The concentrated solution was filtered, thereby removingsolid residues. The pH of the filtrate was adjusted to 7 by adding NaOHsolution, thereby obtaining the liquid extract, as oral solution H.

PREPARATION EXAMPLE NO. 8

The procedure of Preparation Example No. 2 was repeated except that themixture of crude preparation further comprises the following components:Amount (kg) Herba Salviae Chinensis 5 Rhizoma Paridis 1.5

Therefore, oral solution I was obtained.

PREPARATION EXAMPLE NO. 9

The procedure of Preparation Example No. 2 was repeated except that themixture of crude preparation further comprises the following components:Amount (kg) Herba Salviae Chinensis 2.5 Rhizoma Paridis 3

Thereafter, oral solution J was obtained.

PREPARATION EXAMPLE NO. 10

The procedure of Preparation Example No. 2 was repeated except that themixture of crude preparation further comprises the following components:Amount (kg) Radix Ophiopogonis 1 Herba Gynostemmae 1.1 Fructus Corni 1Herba Epimedii 1.2

Thereafter, oral solution K was obtained.

PREPARATION EXAMPLE NO. 11

The procedure of Preparation Example No. 2 was repeated except that themixture of crude preparation comprises the following components: partsby weight Semen Trigonellae 0.95 Astragali Radix 3 Glehniae Radix 3Asparagi Radix 1.5 Fructus Ligustri Lucidi 1 Herba SelaginellaeDoederleinii 2.8 Herba Salviae Chinensis 3 Rhizoma Paridis 1.4 RadixOphiopogonis 0.95 Herba Gynostemmae 0.95 Fructus Corni 0.95 HerbaEpimedii 0.95

Therefore, oral solution L was obtained.

PREPARATION EXAMPLE NO. 12

Preparation of capsules: The procedure of Preparation Example No. 11 wasrepeated except that the following conditions were used. The extractsolution was further vacuum dried (60-70° C), thereby forming solidextract. The solid extract was pulverized, sieved with a 60 mesh screen,mixed with starch powder and packaged into capsules. In this Example,the extract was 60 wt % of the total weight of the composition.

TESTING EXAMPLE NO. 1

The Anti-Tumor Activity of Semen Trigonellae

The animal studies were conducted using C57/BL mice, 6-8 weeks of ageand a body weight of 18-20 g that were bought from the Animal Center(Jiangsu province, China). Under the sterile conditions, 0.2 ml ofsolution (1×10⁷ cell/ml) of cell lines Lewis (lung cancer cell) and S180(sarcoma) was inoculated into the right armpit of mice. On Day 2 afterinoculation, the animals were randomly grouped (10 mice/group). The micein the experimental group were fed with 0.4 ml extract solution of crudepreparation prepared in Example No. 1, solution A (equivalent to 0.4 gdried crude preparation) per day. The mice in the control group were fedwith 0.4 ml physiological saline. On Day 14, the mice were sacrificed.The killing activity of NK cell was measured using mice spleen cells aseffectors and the tumors were weighed.

The results are shown in the following table, indicating the superiorefficiency Semen Trigonellae in inhibiting tumor and enhancing immunity.

Moreover, Astragali Radix, Glehniae Radix, Asparagi Radix, FructusLigustri Lucidi, Fructus Corni also had certain efficiency in inhibitingtumor and/or enhancing immunity. Crude preparation tumor weight (g) NKactivity(%) control 0.63 ± 0.45 18.78 ± 2.33 Semen Trigonellae 0.36 ±0.24 25.61 ± 3.60 Astragali Radix 0.27 ± 0.20 19.43 ± 2.61 GlehniaeRadix 0.58 ± 0.20 19.96 ± 5.52 Asparagi Radix 0.52 ± 0.25 25.67 ± 7.88Fructus Ligustri 0.42 ± 0.25  20.78 ± 19.87 Lucidi Fructus Corni 0.28 ±0.03 26.30 ± 5.32

TESTING EXAMPLE NO. 2

The Anti-Tumor Activity of Composition

Using the same method in Testing Example No. 1, the anti-tumor activityof extracts prepared in Example Nos. 2-11 was tested on thetumor-bearing mice (Lewis cell), except that the test was carried outuntil Day 21 and the administration dose was 0.5 ml/day, equivalent to0.5 g total dry medicinal materials (The concentration of each oralsolution equals to 1 g total dry medicinal materials/1 ml oralsolution).

The results were shown in the following table, indicating the extractsof Semen Trigonellae together with other medicinal materials also hadsuperior efficiency in inhibiting tumor. Transformation tumor rate of Mψ weight lymphocyte NK activity cytotoxicity TH Ts (g) (cpm) (%) (%) (%)(%) saline 1.76 ± 0.73 22755 ± 7744  12.97 ± 2.39  9.76 ± 0.87 49 ± 328.33 ± 1.52 oral 1.02 ± 0.74 31244 ± 14743 20.76 ± 4.10  13.16 ± 1.6154.33 ± 1.15 25 ± 1 solution B oral 1.05 ± 0.74 30322 ± 13625 21.23 ±3.85 14.216 ± 1.52 53.25 ± 1.04 24.25 ± 1.36 solution C oral 1.04 ± 1.0736201 ± 21628  19.4 ± 2.98  13.69 ± 3.47   57 ± 1.52 25.33 ± 2.08solution I oral 0.91 ± 0.41 39260 ± 1970  20.94 ± 6.87  15.55 ± 1.97  58 ± 3.16 24.74 ± 1.78 solution L

TESTING EXAMPLE NO. 3

Clinical Test

The clinical test was carried out at Longhua Hospital, an affiliate ofthe Shanghai University of Traditional Chinese Medicine. 90 volunteersubjects were selected. Each person was checked by chest CT or X-ray,and confirmed to suffer from primary squamous carcinoma of lung oradenocarcinoma of lung or adeno-squamous carcinoma of lung. None of themwas treated by surgery or radiotherapy.

The 90 subjects were divided into 3 groups and treated according to thefollowing regime. Middle survival group regime time (Day) botanical Eachsubject in group of botanical 299 days composition composition treatmentwas administrated 1-3 dosages of oral solution L (Example No. 11) perday, each dosage equivalent to 2 gram of dry Semen Trigonellae.chemotherapy Each subject in group of chemotherapy 206 days treatmentwas treated according to conven- tional chemotherapy regime.chemotherapy + conventional chemotherapy + 1-3 dosages 312 daysbotanical of oral solution L (Example No. 11) composition per day, eachdosage equivalent to 2 gram of dry Semen Trigonellae.

The clinical results indicated that, the composition of the inventioncould significantly extend the life span of the lung cancer patients.(p<0.01, compared with chemotherapy treatment group) and improve thequality of life.

All the documents cited herein are incorporated in the invention asreference, as if each of them is individually incorporated. Further, itwould be appreciated that, in the above teaching of invention, theskilled in the art could make certain changes or modifications to theinvention, and these equivalents would still be within the scope of theinvention defined by the appended claims of the application.

1. A composition comprising: (a) a pharmaceutically acceptable carrier;and (b) an effective amount of an aqueous or aqueous organic solventextract of a crude preparation, which comprises Semen Trigonellae,Astragali Radix, Glehniae Radix, and Asparagi Radix.
 2. The compositionaccording to claim 1, wherein the crude preparation further comprises ananti-tumor medicinal material selected from the group consisting ofFructus Ligustri Lucidi, Herba Selaginellae Doederleinii, andcombination thereof.
 3. The composition according to claim 2, whereinthe crude preparation further comprises an anti-tumor medicinal materialselected from the group consisting of Herba Salviae Chinensis, RhizomaParidis, Salviae Chinensis Herba, Herba Hedyotidis Diffusae, RadixSophorae Tonkinensis, Radix Sophorae Flavescentis, and combinationthereof.
 4. The composition according to claim 3, wherein the crudepreparation further comprises an immunity-enhancing medicinal materialselected from the group consisting of Radix Ophiopogonis, HerbaGynostemmae, Fructus Corni, Herba Epimedii, ginseng, Rhizome ofLargehead Atractylodes, and combination thereof.
 5. The compositionaccording to claim 2, wherein the crude preparation comprises 0.5-5parts by weight Semen Trigonellae, 2-20 parts by weight Astragali Radix,2-10 parts by weight Glehniae Radix, 1-5 parts by weight Asparagi Radix,0.5-5 parts by weight Fructus Ligustri Lucidi, and 1-10 parts by weightHerba Selaginellae Doederleinii.
 6. The composition according to claim5, wherein the crude preparation further comprises 1-10 parts by weightHerba Salviae Chinensis, 1-5 parts by weight Rhizoma Paridis, 1-5 partsby weight Salviae Chinensis Herba, 1-10 parts by weight Herba HedyotidisDiffusae, 1-5 parts by weight Radix Sophorae Tonkinensis, 1-5 parts byweight Radix Sophorae Flavescentis, or combination thereof; and 0.5-10parts by weight Radix Ophiopogonis, 0.5-5 parts by weight HerbaGynostemmae, 0.5-5 parts by weight Fructus Corni, 0.5-5 parts by weightHerba Epimedii, 0.5-5 parts by weight ginseng, 0.5-5 parts by weightRhizome of Largehead Atractylodes, or combination thereof.
 7. Thecomposition according to claim 4, wherein the crude preparationcomprises: 0.5-5 parts by weight Semen Trigonellae, 2-20 parts by weightAstragali Radix, 2-10 parts by weight Glehniae Radix, and 1-5 parts byweight Asparagi Radix; 0.5-5 parts by weight Fructus Ligustri Lucidi,and 1-10 parts by weight Herba Selaginellae Doederleinii; 1-10 parts byweight Herba Salviae Chinensis, and 1-5 parts by weight Rhizoma Paridis;and 0.5-10 parts by weight Radix Ophiopogonis, 0.5-5 parts by weightHerba Gynostemmae, 0.5-5 parts by weight Fructus Corni, and 0.5-5 partsby weight Herba Epimedii.
 8. The composition according to claim 4,wherein the crude preparation comprises: 0.7-3 parts by weight SemenTrigonellae, 2.5-10 parts by weight Astragali Radix, 2.5-6 parts byweight Glehniae Radix, and 1.2-3.5 parts by weight Asparagi Radix; 0.7-3parts by weight Fructus Ligustri Lucidi, and 2.5-6 parts by weight HerbaSelaginellae Doederleinii; 2-8 parts by weight Herba Salviae Chinensis,and 1.2-3.5 parts by weight Rhizoma Paridis; 0.7-5 parts by weight RadixOphiopogonis, 0.7-3 parts by weight Herba Gynostemmae, 0.7-3 parts byweight Fructus Corni, and 0.7-3 parts by weight Herba Epimedii.
 9. Amethod for preparing a composition, wherein the composition comprises apharmaceutically acceptable carrier and an effective amount of anaqueous or aqueous organic solvent extract of a crude preparation, thecrude preparation comprising Semen Trigonellae, Astragali Radix,Glehniae Radix, and Asparagi Radix, the method comprising the followingsteps: (a) mixing the crude preparation with water or aqueous solutioncontaining 30-85% (v/v) ethanol for 12-48 hrs to form a mixture; (b)filtering the mixture to obtain the filtrate, adjusting the pH of thefiltrate to 4-8, thereby obtaining an extract; or adjusting the pH ofmixture to 4-8 and filtering the mixture to obtain the filtrate, therebyobtaining an extract; and (c) mixing the extract with a pharmaceuticallyacceptable carrier, thereby forming the composition.
 10. The methodaccording to claim 9, wherein the step (b) further comprises the step ofdrying the obtained extract.
 11. The method according to claim 9,wherein the crude preparation further comprises: a medicinal materialselected from the group consisting of Fructus Ligustri Lucidi, HerbaSelaginellae Doederleinii, and combination thereof; an anti-tumormedicinal material selected from the group consisting of Herba SalviaeChinensis, Rhizoma Paridis, Salviae Chinensis Herba, Herba HedyotidisDiffusae, Radix Sophorae Tonkinensis, Radix Sophorae Flavescentis, andcombination thereof; and an immunity-enhancing medicinal materialselected from the group consisting of Radix Ophiopogonis, HerbaGynostemmae, Fructus Corni, Herba Epimedii, ginseng, Rhizome ofLargehead Atractylodes, and combination thereof.
 12. A method fortreating cancer comprising administrating to the subject in need acomposition which comprises (a) a pharmaceutically acceptable carrierand (b) an effective amount of an aqueous or aqueous organic solventextract of a crude preparation comprising Semen Trigonellae.
 13. Themethod according to claim 12, wherein the crude preparation furthercomprises Astragali Radix, Glehniae Radix, Asparagi Radix, FructusLigustri Lucidi and Herba Selaginellae Doederleinii.
 14. The methodaccording to claim 12, wherein the effective amount is 1-3 dosages perperson per day, and wherein each dosage is equivalent to 0.5-15 gram ofdry Semen Trigonellae.